Inception of the program implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the numbers of waived testsĪnd the sites that perform them have increased dramatically. These advances have enabled more testingīe performed in emergency departments, hospital rooms, and physicians' offices and in nontraditional testing sites suchĪs community counseling centers, pharmacies, nursing homes, ambulances, and health fairs. Using compact or hand held devices by personnel with limited experience and training. Instrumentation suitable for use by highly trained personnel in traditional clinical laboratory settings. Prothrombin time, cholesterol, and glucose either used complex manual methodologies or were performed using sizable Training, quality control (QC) (unless specified as required in the test system instructions), proficiency testing (PT), and routineĪdvances in technology have made tests simpler, contributing to this shift in testing. Requirements for personnel qualifications and Oversight requirements (and are thus designated as waived tests), including Increasingly, these decisions are based on simple tests performed at the point-of-care using devices that are waived from most federal The United States ( 1,2), and laboratory test results influence approximately 70% of medical decisions An estimatedħ-10 billion laboratory tests are performed each year in More laboratory tests conducted during their lifetime. Laboratory testing affects persons in every life stage, and almost everyone will experience having one or Results contribute to diagnosis and prognosis of disease, monitoring of treatment and health status, and population screeningįor disease. Laboratory testing plays a critical role in health assessment, health care, and ultimately, the public's health. Continued monitoring of waived testing, with a focus on personnel educationĪnd training, is needed to improve practices and enhance patient safety as waived testing continues to increase. Improving their knowledge of good laboratory practices. They are intended to be used by those who would benefit from (control testing, test performance, and result interpretation and recording), and 3) after testing (result reporting,ĭocumentation, confirmatory testing, and biohazard waste disposal). Practices for the three phases of testing: 1) before testing (test ordering and specimen collection), 2) during testing Safety, physical and environmental requirements, benefits and costs, staffing, and documentation. Include considerations before introducing waived testing, such as management responsibility for testing, regulatory requirements, This report summarizes study findings and provides recommendations developed by theĬlinical Laboratory Improvement Advisory Committee for conducting quality waived testing. These issuesĪre probably caused, in part, by high personnel turnover rates, lack of understanding about good laboratory practices,Īnd inadequate training. Although study findings indicate CW sites generally take measures to perform testingĬorrectly, they raise quality concerns about practices that could lead to errors in testing and poor patient outcomes. Medicare & Medicaid Services and studies funded by CDC during 1999-2003 evaluated testing practices in sites holding aĬLIA Certificate of Waiver (CW). Surveys conducted during 1999-2004 by the Centers for Implemented, waived testing has steadily increased in the United States. Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), simple, low-risk tests can be waivedĪnd performed with no routine regulatory oversight in physicians' offices and various other locations. Bernhardt, PhD, Director and the Division of Public Health Partnerships, Robert Martin, DrPH, Director.Ĭorresponding author: Devery Howerton, PhD, National Center for Health Marketing,Ĭoordinating Center for Health Information and Service Ĥ770 Buford Hwy NE, MS G-23, Atlanta, GA, 30341. National Center for Health Marketing, Jay M. ![]() The material in this report originated in the Coordinating Center for Health Information and Service, Steven L. The Clinical Laboratory Improvement Amendments of 1988Īnd Recommendations for Promoting Quality Testingĭevery Howerton, PhD, Nancy Anderson, MMSc, Diane Bosse, MS, Sharon Granade, Glennis Westbrookĭivision of Public Health Partnerships, National Center for Health Marketing, Coordinating Center for Health Information and Service Survey Findings from Testing Sites Holding a Certificate of Waiver Under Good Laboratory Practices for Waived Testing Sites ![]() For assistance, please send e-mail to: Type 508 Accommodation and the title of the report in the subject line of e-mail. Persons using assistive technology might not be able to fully access information in this file.
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